Urinary incontinence is a wide spread disorder. It is particularly disconcerting to those who suffer from the disorder, and often times demeaning when sufferers are confronted with the reality that they may need to be catheterized for an extended period of time, perhaps indefinitely.
Stress incontinence is a relatively common disorder among post-menopausal women. This disorder often results from prior injuries occurring during child birth. At least some of the women suffering this disorder seek surgical solutions to restore urinary continence so that catheterization will be unnecessary. As women from the post-war baby boom generation advance in age, it is believed that the number of women seeking such solutions will increase.
One such surgical solution, which has been used in the past, is to implant a pubovaginal sling to provide urethral and pelvic support for the female urogenital organs in an attempt to restore urinary continence. The sling is used to raise the urethra and support it, and to enable the urethra to remain closed under fluid pressure from the bladder. C. Mason et al., American Urological Association, Annual Convention, 1996, report that pubovaginal sling cystourethropexy has become the "mainstay" of surgical therapies for Type III Stress Urinary Incontinence (SUI). However, many patients undergoing this procedure are reported to be plagued with unexpected urinary retention or detrusor instability post-operatively. F. E. Govier, American Urological Association, Annual Convention, 1996, reports the management of Intrinsic Sphincteric Deficiency (ISD) by constructing a pubovaginal sling from existing tissues within the patient's body. Dr. Govier treated a number of female patients having urodynamically-proven ISD. A pubovaginal sling was created using a portion of the fascia lata from each of the respective patients. An unscarred facial strip approximately 20-24 cm by 2.5 cm was obtained by making several incisions in the patient's thigh in order to provide material for the sling. The sling was attached to itself over a 3-4 cm bridge of the rectus fascia. This treatment was reported to provide excellent results due in part to advantages provided by the length the strip of fascia lata, which was reportedly long enough to be attached to itself to enable the surgeon to provide sufficient tension to the sling to obtain the desired result. The uniform thickness and width of the graft was also reported to allow for excellent urethral closure, minimizing the chance of obstruction. Furthermore, since the procedure did not involve an abdominal incision, it was reported that hospital stays were relatively short, that full activity was achievable at two weeks and that there was little or no post-operative chance of an abdominal wall hernia resulting from the procedure.
It will be appreciated, however, that other solutions which do not require the use of autologous tissues will be desirable to some patients. This is especially because the surgical removal of such tissue is not required. In addition, autologous tissues may go through undesirable changes that will not occur in other materials. Furthermore, selecting and shaping the strip may require considerable skill which may not be within the capability of all surgeons conducting the procedure.
Accordingly, it will be appreciated that there remains a need for an efficient, price competitive pubovaginal sling device which will be an improvement over the previously mentioned slings and other prior art devices. The present invention also provides advantages over the prior art methods for manufacturing sling devices, methods of surgically restoring urinary continence, and also offers other advantages over the prior art and solves other problems associated therewith.